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Ear, Nose, Throat

3,794 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
FINETONE FSC, (K955692)Finetone Hearing Instruments1996-02-02
TREBAY MICRODEBRIDER SYSTEM (K955704)Trebay Medical Corp.1996-01-30
MIRACLE EAR MIRAGE (K954119)Miracle-Ear, Inc.1996-01-24
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS (K954922)Rexton, Inc.1996-01-17
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY (K954797)KARL STORZ Endoscopy-America, Inc.1996-01-17
MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE (K955616)Misten Medical Corp.1996-01-17
TREBAY SCOPE IRRIGATED CLEARING SLEEVE (K955560)Trebay Medical Corp.1995-12-22
MIRACLE EAR AND AUDIOTONE (K954941)Miracle-Ear, Inc.1995-12-22
MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS (K955615)Misten Medical Corp.1995-12-22
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI (K955574)Resound Corp.1995-12-22
MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (K955613)Misten Medical Corp.1995-12-22
NERVE LOCATOR/MONITOR SYSTEM MODIFICATION (K954601)Rln Systems, Inc.1995-12-22
SOF - ABRASION BUR (K955294)Trebay Medical Corp.1995-12-22
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH (K942265)Vision-Sciences, Inc.1995-12-22
EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY (K955593)Shippert Medical Technologies Corp.1995-12-22
TYMPANOSTOMY TUBE (K955447)Trebay Medical Corp.1995-12-21
OPTUS BRONCHOSCOPES (K945268)Optus, Inc.1995-12-21
EASY BREATHING NASAL STRIPS (K955233)Corbett Lair, Inc.1995-12-21
OTOSCAPE (K953814)Soundscape Technologies, Inc.1995-12-21
CYBER III OPTION UM, UC312, UC10, UCIC (K955359)Qualitone1995-12-19
E-Z BREATHERS (K953042)E-Z Kare Good Health Systems, Inc.1995-12-08
RACE CAR TYMPANOMETER (K955289)American Electromedics Corp.1995-12-08
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION (K954579)Telex Communications, Inc.1995-12-08
FACEPLATE (HEARING AID KIT) (K954236)Truetone Hearing Systems, Inc.1995-12-06
TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (K954912)Trebay Medical Corp.1995-12-06
BELTONE ULTIMA 80 OTOSONIC POWER PAS (K954936)Beltone Electronics Corp.1995-12-06
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (K945876)Wells Johnson Co.1995-12-04
PROLASTIC SHEETING (K954382)Pillar Surgical1995-11-29
EXPANDACELL INJECTO-PAK NASAL PACK (K954845)Shippert Medical Technologies Corp.1995-11-27
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES (K954989)Smith & Nephew Dyonics, Inc.1995-11-27
POCKETALKER PRO (K954748)Williams Sound, LLC1995-11-22
OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS (K953771)KARL STORZ Endoscopy-America, Inc.1995-11-22
BRONCHOSCOPE (K954707)Fujinon, Inc.1995-11-22
HYDROCELL NASAL AND SINUS PACKS (K954491)Smith & Nephew Richards, Inc.1995-11-15
AT2 & DOYLE STYLE (C-FLEX) VENT TUBES (K954795)Trebay Medical Corp.1995-11-15
GLANZ CARCINOMA GAUGE, KSEA (K954348)KARL STORZ Endoscopy-America, Inc.1995-11-15
ENT PACKINGS, WICKS, WIPES, AND SPONGES (K954449)Oasis1995-11-14
WELCH ALLYN BI-OTOSCOPE (K955043)Welch Allyn, Inc.1995-11-14
HEARING TODAY HEARING AID (K953603)Hearing Today Laboratory, Inc.1995-11-13
ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE) (K954336)Aust & Taylor Medical Corp.1995-11-13
OTICON (K954794)Oticon, Inc.1995-11-13
COAST HEARING CHS (CUSTOM HEARING SYSTEM) (K954937)Coast Hearing Services1995-11-13
JED-LIGHT FIBEROPTIC LIGHT SOURCE (K954184)Jedmed Instrument Co.1995-11-13
MICRO-INGRESSOR HANDIPIECE (K954796)Trebay Medical Corp.1995-11-06
KARL STORZ OPTICAL MEDIASTINOSCOPE (K954910)KARL STORZ Endoscopy-America, Inc.1995-11-03
TREBAY TOTAL RECTANGULAR HEAD (K954518)Trebay Medical Corp.1995-10-27
TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT (K954517)Trebay Medical Corp.1995-10-27
PROPHET (K953884)Qualitone1995-10-27
GSI 61 CLINICAL AUDIOMETER (K953684)Grason-Stadler, Inc.1995-10-27
MICRO-PLANER HANDPIECE (K954715)Trebay Medical Corp.1995-10-27
BURGET NASAL STENT (K942025)Bivona Medical Technologies1995-10-27
TYMPANOSTOMY TUBE (K953802)Bluff City Medical Technologies, Inc.1995-10-24
BREATHE RIGHT NASAL STRIP (K953772)Cns, Inc.1995-10-20
BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS (K942651)Casa Futura Technologies1995-10-19
EASY BREATHING NASAL STRIPS (K954252)Corbett Lair, Inc.1995-10-18
WIDEX SENSO DIGITAL (PX) (K954526)Widex Hearing Aid Co., Inc.1995-10-18
UNITRON MODEL SOUND F/X II (K954516)Unitron Industries, Inc.1995-10-07
UNITRON MODEL IKON AOHPD (K953727)Unitron Industries, Inc.1995-10-07
TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE (K953888)Vista Medical Technologies, Inc.1995-10-07
UNITRON MODEL SOUND F/XD (K953932)Unitron Industries, Inc.1995-10-07
MIRACLE - EAR MODEL PBP (K954528)Miracle-Ear, Inc.1995-10-07
UNITRON MODEL SOUND F/X (K954430)Unitron Industries, Inc.1995-10-06
SAUER ENDOSCOPE GUIDE AND INTUBATION AID (K954125)KARL STORZ Endoscopy-America, Inc.1995-10-06
3M MODEL 8295 (K954067)3M Company1995-09-28
MAICO PRODIGY CIC SERIES (K954054)Maico Hearing Instruments, Inc.1995-09-28
DISTENDING DIVERTICULOSCOPE (K953596)KARL STORZ Endoscopy-America, Inc.1995-09-26
REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY (K953770)Rexton, Inc.1995-09-18
AMENDMENTS TO MULTIFOCUS (K951002)Oticon A/S1995-09-18
PHONAK 9900 CIC (K953921)Phonak, Inc.1995-09-18
K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT (K954038)Argosy Electronics1995-09-18
VIDEO SCOPE SYSTEM (LARYNGOSCOPE) (K944032)Jedmed Instrument Co.1995-09-15
HEARING AID (ALL-IN-THE-EAR) (K951712)Omega Hearing Aid Center1995-09-12
HEARING AID (ALL-IN-THE-EAR) (K953960)Audina Hearing Instrument1995-09-12
K AMP FULL SHELL AND IN THE EAR (K953729)Midwest City Hearing Aid Center1995-09-12
RX12 LINEAR FULL SHELL AND IN THE CANAL (K953728)Midwest City Hearing Aid Center1995-09-12
TYMPASNOSTOMY TUBE (K953993)Hampton Precision Products, Inc.1995-09-12
KARL STORZ ENT SHAVER (K953370)KARL STORZ Endoscopy-America, Inc.1995-09-06
PRISM ELECTROSCOPE (K953849)KARL STORZ Endoscopy-America, Inc.1995-09-06
MEDICAL GRADE SILICONE BLOCK (K952732)Bioplexus Corp.1995-08-31
MEROCEL REINFORCED SILICONE SHEETS (K953013)Merocel Corp.1995-08-29
UNITRON MODEL IKON AOHPL (K953646)Unitron Industries, Inc.1995-08-28
SNIP INPUT COMPRESSION CLASS A (K953631)Midwest City Hearing Aid Center1995-08-28
PHONAK PICONET 232X-AZ HEARING INSTRUMENT (K945439)Phonak, Inc.1995-08-23
KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL (K950337)KARL STORZ Endoscopy-America, Inc.1995-08-23
3M MODEL 8200P MULTIPRO BTE (K953543)3M Company1995-08-23
Z20 (K953047)Electone, Inc.1995-08-22
Z33 (K953050)Electone, Inc.1995-08-22
Z35 (K953051)Electone, Inc.1995-08-15
AM 260 K-AMP (K953052)Electone, Inc.1995-08-15
Z22 (K953048)Electone, Inc.1995-08-15
AM 260 OHM (K953054)Electone, Inc.1995-08-15
Z24 (K953049)Electone, Inc.1995-08-15
AM 260 PP (K953053)Electone, Inc.1995-08-15
C-FLEX SEPTAL SPLINTS (K952226)Trebay Medical Corp.1995-08-11
JEDMED LARYNGEAL SCOPE (K950925)Jedmed Instrument Co.1995-08-11
JEDMED SPECTRUM ENT CABINET (K953457)Jedmed Instrument Co.1995-08-11
SPI-SECRET PERSONAL INSTRUMENT CIC (K952986)Midwest City Hearing Aid Center1995-08-07
REDI DRILL DRILL SYSTEM (K952609)Trebay Medical Corp.1995-07-31
ESSENTIAL SHAVER SYSTEM (K953096)Smith & Nephew Richards, Inc.1995-07-28
HEARING AID (K952658)Philips Hearing Instruments Co.1995-07-28
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